MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506)

Patient Problems Death (1802); Embolism (1829); Hemorrhage/Bleeding (1888); Great Vessel Perforation (2152); Anxiety (2328); Depression (2361); Thrombosis/Thrombus (4440)

Event Type  Death  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter occupation: non-healthcare professional summary of investigational findings: the following allegations have been investigated: pulmonary embolism (pe), inferior vena cava perforation, embedment, death, bleeding.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported death and bleeding are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Description of event according to initial reporter: it is alleged that "on or about (b)(6) 2020, [pt] was implanted with a cook celect filter.[pt]¿s cook celect filter subsequently malfunctioned and caused injury and damages to her, including death, as a result of the cook celect filter.[pt] suffered a retroperitoneal bleed due to perforation of her inferior vena cava and multiple pulmonary-thrombo embolism emanating from the filter.[pt]¿s filter was also embedded in her ivc and penetrating through it." patient outcome: it is alleged that "the cook celect filter directly caused [pt]'s death.".

Manufacturer Narrative

The following fields were updated per additional information received: a2, a4, b2 (date of death), b5, b6, b7, d1, d4, g4, h4, annex e, annex f, annex a, annex b, annex c, annex d, and h6.Investigation: the following allegations have been investigated: retroperitoneal bleed, thrombus/ deep vein thrombosis (dvt), and depression/anxiety.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.The additional information regarding retroperitoneal bleed does not change the previous investigation results for bleeding.Unknown if the reported death and bleeding are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown, however, the alleged celect is manufactured and inspected according to controls.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

The patient received an implant on (b)(6) 2010 via the right femoral vein due to pulmonary embolism (pe).Allegations include: vena cava perforation, bleeding, and death.It has been noted and further alleged the patient experienced retroperitoneal bleeding which resulted in death, thrombus, pulmonary embolism which also contributed to death and depression/anxiety.Per certificate of death, dated on (b)(6) 2018, immediate cause of death is retroperitoneal bleed.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10710031
• MDR Text Key: 212243822
• Report Number: 3002808486-2020-00978
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Weight: 159